KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Solid State X-Ray Imager (Flat Panel/Digital Imager) (MQB) (9) System, X-Ray, Stationary (KPR) (2)

Premarket Exempt

No Yes

Clear

17X17 GOS Fixed Flat Panel Detector - 00817100020223 Catalog Number :

Device Description : IR 17X17 GOS Fixed Flat Panel Detector (-R or -L)

Device Class : 2

Duns Number: 080269345

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

14X17 Portable GOS Flat Panel Detector - 00817100020230 Catalog Number :

Device Description : IR 14X17 Portable GOS Flat Panel Detector (-R or -L)

Device Class : 2

Duns Number: 080269345

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

14X17 Portable GOS Flat Panel Detector without USB - 00817100020247 Catalog Number :

Device Description : IR 14X17 Portable GOS Flat Panel Detector without USB (-R or -L)

Device Class : 2

Duns Number: 080269345

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

14X17 Wireless GOS Flat Panel Detector - 00817100020254 Catalog Number :

Device Description : IR 14X17 Wireless GOS Flat Panel Detector -R or -L)

Device Class : 2

Duns Number: 080269345

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

4343 CsI Digital Flat Panel Detector - 00817100020261 Catalog Number :

Device Description : THL 4343 CsI Digital Flat Panel Detector-R

Device Class : 2

Duns Number: 080269345

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

3543EZ CsI Digital Wireless Flat Panel Detector - 00817100020285 Catalog Number :

Device Description : THL 3543EZ CsI Digital Wireless Flat Panel Detector-R

Device Class : 2

Duns Number: 080269345

Premarket Exempt : No

Product Code : MQB, KPR

Prescription Use : Yes

Device Count : 1

4143C CsI Compact Digital Flat Panel Detector - 00817100020308 Catalog Number :

Device Description : THL 4143C CsI High Resolution Digital Flat Panel Detector-R

Device Class : 2

Duns Number: 080269345

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

RF 14X17 Sensor Panel - 00817100020315 Catalog Number :

Device Description : RF 14X17 Sensor Panel-R

Device Class : 2

Duns Number: 080269345

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

14X17 Flat Panel Detector - 00817100020322 Catalog Number :

Device Description : SMS 14X17 Flat Panel Detector-R

Device Class : 2

Duns Number: 080269345

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

Flat Panel Detector - 00817100020339 Catalog Number :

Device Description : THL Flat Panel Detector-R

Device Class : 2

Duns Number: 080269345

Premarket Exempt : No

Product Code : KPR

Prescription Use : Yes

Device Count : 1

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